Trinity™ BIOLOX Delta™ CoC THR Multi-center Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Corin
Sponsor:
Information provided by (Responsible Party):
Corin
ClinicalTrials.gov Identifier:
NCT01921309
First received: June 10, 2013
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

To demonstrate the safety and effectiveness of the Trinity™ BIOLOX delta™ Ceramic-on-Ceramic Total Hip System in comparison to the Trinity™ Acetabular Hip System,which is FDA cleared for use in the U.S. The comparison will be based upon clinical success at the Month 24 endpoint.


Condition Intervention Phase
Osteoarthritis
Avascular Necrosis
Rheumatoid Arthritis
CDH
Device: Trinity CoC Total Hip System
Device: Trinity Ceramic-on-Poly THR
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Phase 3 Randomized Controlled Study to Demonstrate Safety and Effectiveness of the BIOLOX Delta CoC THR System

Resource links provided by NLM:


Further study details as provided by Corin:

Primary Outcome Measures:
  • Composite Clinical Success [ Time Frame: 24 months post-operative ] [ Designated as safety issue: Yes ]
    • HHS ≥ 80 at Month 24 (good/excellent)
    • No serious, definitely device related complications with onset on or prior to Month 24
    • No radiographic failure at Month 24
    • No removal, replacement, or modification of any component on or prior to Month 24.


Secondary Outcome Measures:
  • HHS [ Time Frame: 24 months post-operative ] [ Designated as safety issue: No ]
    • Individual components of the Harris Hip Score (total score, pain and function).

  • HOOS score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Hip injury and Osteoarthritis Outcome Score (HOOS).

  • pain [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    VAS pain score

  • survival [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Kaplan-Meier survival curve

  • adverse events [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Summary of device-related complications


Estimated Enrollment: 402
Study Start Date: December 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trinity CoC Total Hip System
total hip replacement with a ceramic femoral head and ceramic acetabular cup liner
Device: Trinity CoC Total Hip System
total hip replacement with a ceramic femoral head which moves on a ceramic acetabular cup liner
Active Comparator: Trinity Ceramic-on-Poly THR
total hip replacement with a ceramic femoral head and polyethylene acetabular cup liner
Device: Trinity Ceramic-on-Poly THR
total hip replacement with a ceramic femoral head which moves on a highly cross-linked ultra high molecular weight polyethylene acetabular cup liner

Detailed Description:

The clinical research results for the Trinity™ BIOLOX delta™ Ceramic-on-Ceramic Total Hip System will be compared to the control device

Clinical success is based upon Harris Hip Scores to evaluate functional status, adverse events, radiological assessments and no device failure (defined as removal, replacement, or modification of any device component).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. preoperative Harris Hip Score of ≤ 70.
  2. preoperative Harris Hip Total Pain score of at least moderate.
  3. diagnosed with non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, rheumatoid arthritis, correction of functional deformity, developmental hip dysplasia (DDH) and congenital hip dysplasia (CDH).
  4. pain rating of none or slight and are at least 12 months post-operative in the contralateral hip, if applicable.
  5. have sufficient femoral and acetabular bone stock as determined by a clinician, and are suitable to receive implants as confirmed by x-rays.

Exclusion Criteria:

  1. have a nutritional problem (protein, calorie, or vitamin/mineral deficiency) that may impair wound healing mechanisms as determined by the clinician /investigator.
  2. have a neurological disorders which may interfere or adversely affect gait, balance, or weight bearing (e.g. muscular dystrophy, multiple sclerosis).
  3. diagnosed with metabolic disorders (e.g. osteomalacia), which may impair bone metabolism.
  4. diagnosed systemic disease that would affect their welfare or the overall outcome of study (i.e. Paget's disease, renal osteodystrophy)
  5. immunologically suppressed.
  6. receiving systemic steroid therapy, excluding inhalers, within 3 months prior to surgery.
  7. diagnosed Charcot's disease, metastatic or neoplastic disease.
  8. evidence of active infections that may spread to other areas of the body (e.g. osteomyelitis, pyogenic infection of the hip joint, overt infection, untreated urinary tract infection, etc.).
  9. presence of a previous prosthetic hip replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.) in the hip joint to be operated.
  10. previous Girdlestone procedure (resection arthroplasty) or surgical fusion of the hip to be operated.
  11. diagnosed with systemic lupus erythematosus, pigmented villonodular synovitis, juvenile rheumatoid arthritis or other diagnoses with autoimmune etiology.
  12. diagnosed with osteoporosis or as evidenced on a DEXA scan for males over 75 or females over 65 years of age (within the last 12 months).
  13. require structural bone grafts in order to support the prosthetic component(s) or to shape the bone to receive the implant(s).
  14. have acute femoral neck fracture or hip fractures.
  15. have an above the knee amputation of the contralateral and/or ipsilateral leg.
  16. have an existing total hip arthroplasty in the contralateral hip with a pain rating of 3 or more on a scale of 0 to 10, where 0 is "no pain" and 10 is "severe pain".
  17. have had a total hip arthroplasty in the contralateral hip within the past 12 months.
  18. have previously received a metal-on-metal hip arthroplasty.
  19. have a highly communicable disease or diseases that may limit follow-up (e.g. immunocompromised conditions, hepatitis, active tuberculosis, etc.).
  20. have any known sensitivity to device material.
  21. Females who are pregnant.
  22. Patients who are prisoners.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01921309

Contacts
Contact: Weslynn Baird 813-977-4469 Weslynn.Baird@coringroup.com
Contact: Katie Kolb 813-977-4469 katie.kolb@coringroup.com

Locations
United States, Arkansas
Arkansas Specialty Orthopaedics Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Cara Petrus    501-246-4439    cpetrus@hipkneearkansas.com   
Principal Investigator: C. Lowry Barnes, M.D.         
Sub-Investigator: Paul Edwards, M.D.         
Sub-Investigator: Gordon Newbern, M.D.         
United States, Connecticut
Connecticut Joint Replacement Institute (CJRI) Recruiting
Hartford, Connecticut, United States, 06105
Contact: Patricia McLean    203-598-0700 ext 7005    pmclean@ospc1579.com   
Principal Investigator: John Keggi, MD         
United States, Florida
Mayo Clinic Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Contact: Shari Kazmerchak    904-953-8354    kazmerchak.shari@Mayo.edu   
Principal Investigator: Mary O'Connor, M.D.         
Sub-Investigator: Kurt Blasser, M.D.         
Sub-Investigator: Courtney Sherman, M.D.         
Sub-Investigator: Mark Brodersen, M.D.         
Florida Orthopaedic Institute Recruiting
Tampa, Florida, United States, 33609
Contact: Page Lane    813-558-6834    page.lane@foreonline.org   
Principal Investigator: David Watson, M.D.         
Sub-Investigator: Michael Miranda, D.O.         
United States, Minnesota
Mayo Clinic Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Char Blanchard    507-284-1175    blanchard.charlene@mayo.edu   
Principal Investigator: Robert Trousdale, M.D.         
United States, North Carolina
OrthoCarolina Hip & Knee Center Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Barbara Davis    704-323-2269    barbara.davis@orthocarolina.com   
Principal Investigator: John Masonis, M.D.         
United States, Texas
Memorial Bone & Joint Recruiting
Houston, Texas, United States, 77043
Contact: Ashish Arya    713-936-1663    aarya@mbjc.net   
Principal Investigator: Stefan Kreuzer, M.D.         
Sub-Investigator: Adam Freedhand, MD         
Sponsors and Collaborators
Corin
Investigators
Study Director: Kathy Trier, Ph.D. Corin
  More Information

Additional Information:
No publications provided

Responsible Party: Corin
ClinicalTrials.gov Identifier: NCT01921309     History of Changes
Other Study ID Numbers: G120038, #G120038
Study First Received: June 10, 2013
Last Updated: March 31, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Corin:
osteoarthritis
avascular necrosis
rheumatoid arthritis
correction of functional deformity
dysplasia of the hip

Additional relevant MeSH terms:
Osteonecrosis
Arthritis
Arthritis, Rheumatoid
Osteoarthritis
Necrosis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Bone Diseases

ClinicalTrials.gov processed this record on October 19, 2014